What side effects are associated with this type of intervention?

Common treatments for mesothelioma, particularly those involving targeted therapies and immune checkpoint inhibitors similar to IAG933, often have side effects such as gastrointestinal issues (diarrhea, nausea, vomiting), cutaneous reactions (rash, acne, dry skin, pruritus), and immune-related toxicities (pneumonitis). These treatments can also lead to hematologic adverse effects like anemia, thrombocytopenia, and neutropenia. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for mesothelioma include immune checkpoint inhibitors such as nivolumab and ipilimumab. Nivolumab, alone or in combination with ipilimumab, has shown efficacy in treating relapsed malignant pleural mesothelioma. These treatments focus on enhancing the immune response against cancer cells. While the context does not provide specific information on FDA-approved treatments targeting the YAP/TAZ signaling pathway like IAG933, the use of immune checkpoint inhibitors represents a significant advancement in the treatment of mesothelioma.

What other types of research exist?

Promising novel alternatives to IAG933 for Mesothelioma patients include immune checkpoint inhibitors like pembrolizumab, which have shown efficacy in various cancers, and mTOR inhibitors such as temsirolimus, which have demonstrated potential in other solid tumors. Additionally, investigational agents targeting the PI3K/PTEN/AKT/mTOR pathway may offer new therapeutic options.

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CAR T-cell Therapy

IAG933 for Mesothelioma

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dose escalation part: patients with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma or other solid tumors.

Patients with solid tumors other than mesothelioma must have local available data for loss-of-function NF2/LATS1/LATS2 genetic alterations (truncating mutation or gene deletion; LATS1/LATS2 mutations will only be included in the dose escalation part), or functional YAP/TAZ fusions.

Must not have

Insufficient bone marrow function at screening.

Japan only: patients with a history of drug- and/or non-drug-induced interstitial lung disease (ILD) ≥ Grade 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called IAG933 in patients with specific types of tumors. It aims to find the safest and most effective dose and see if the drug can help shrink the tumors.

Who is the study for?

This trial is for adults with advanced mesothelioma or solid tumors that have specific genetic mutations (NF2, LATS1/LATS2) or YAP/TAZ fusions. Participants must have tried all standard treatments without success, be unable to tolerate them, or no standard treatment exists. They should also be able to undergo a tumor biopsy and not have other serious health issues like poor bone marrow, kidney, liver function, significant heart disease risks, active COVID-19 infection or a history of certain lung diseases.

What is being tested?

The study tests IAG933's safety and tolerability in patients with advanced mesothelioma and other solid tumors. It aims to find the highest dose patients can take without severe side effects (maximum tolerated dose) and suggest an optimal dose for further studies.

What are the potential side effects?

While the exact side effects are not listed here as it's a Phase I trial primarily assessing safety and tolerability, common side effects in such trials may include nausea, fatigue, allergic reactions at the infusion site if applicable, headaches and potentially more depending on how the drug affects the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an advanced cancer that cannot be surgically removed.

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My tumor has specific genetic changes not related to mesothelioma.

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My cancer diagnosis was confirmed through tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My bone marrow is not working well.

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I have had a serious lung condition from medication or other causes.

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My liver is not working properly.

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I have heart problems or risk factors for heart disease.

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I currently have an active COVID-19 infection.

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I have never been treated with a TEAD inhibitor.

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I do not have any other cancer besides the one being treated in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)

Number of patients with adverse events and serious adverse events

Number of patients with dose interruptions and dose changes

Secondary study objectives

Accumulation ratio (Racc) (dose escalation only)

Area under the curve (AUC)

Disease control rate (DCR)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4Experimental Treatment1 Intervention

Non-pleural mesothelioma

Group II: Group 3Experimental Treatment1 Intervention

Solid tumors with functional YAP/TAZ fusions

Group III: Group 2Experimental Treatment1 Intervention

NF2 truncating mutations or deletions

Group IV: Group 1Experimental Treatment1 Intervention

Malignant pleural mesothelioma

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mesothelioma include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy typically uses drugs like pemetrexed and cisplatin to kill rapidly dividing cancer cells. Immunotherapy, such as nivolumab and pembrolizumab, enhances the body's immune response against cancer cells by inhibiting checkpoints like PD-1/PD-L1. Targeted therapies, including the investigational drug IAG933, focus on specific molecular pathways involved in cancer growth. IAG933 inhibits the YAP/TAZ signaling pathway, which is crucial in cell proliferation and survival in Mesothelioma. This pathway is often dysregulated in Mesothelioma, making it a promising target. Understanding these mechanisms helps tailor treatments to disrupt cancer growth effectively, offering hope for better outcomes in Mesothelioma patients.

Hippo pathway inhibition by blocking the YAP/TAZ-TEAD interface: a patent review.Analysis of YAP1 and TAZ expression by immunohistochemical staining in malignant mesothelioma and reactive mesothelial cells.